This invention is directed to reagent packaging devices for storing one or more ingredients or reagents separate from one another in a single reagent package for subsequent mixing in the reagent package, and more particularly to a novel reagent package having a valve controlled opening that can be sealed independently of the valve. The invention is also directed to a reagent package having a novel liquid flow director system for directing substantially all liquid on a floor of the package into a liquid aspiration area and for preventing any minute glass particles that may surround the liquid aspiration area from entering the aspiration area.
Automated sample analysis systems as disclosed in U.S. Pat. Nos. 5,268,167 and 5,399,497 can perform a variety of different tests on a test subject, such as a serum sample, in a relatively short period of time. Generally the serum sample is separated into a predetermined number of segregated portions and a different test is usually performed on each segregated portion of the serum sample. It is thus common practice to divide the serum sample into a series of separate isolated sample segments that correspond to each separate test. The isolated sample segments are enabled to co-act with specific reagents to produce an analyzable reaction that forms the basis for a test result.
Different reagents will produce different test results on respective sample segments and the compendium of the separate test results provide a body of information or data relating to the characteristics of the serum sample.
As used herein, the term reagent is intended to refer to a single reagent, a mixture of two or more reagents and/or a mixture of reagent with a reconstituting liquid.
Reagents for sample analysis systems are preferably used in liquid form to permit allotment of a precise predetermined amount of reagent to each sample segment and to help ensure that the reaction between the reagent and the serum sample is uniform. Generally, the reagent is diluted to a desired concentration before it is permitted to co-act with a serum sample.
It is well known that some reagents used in sample analysis systems have a limited shelf life especially if produced as a solution of one or more reagent components. Therefore, optimum test results between a reagent and a serum sample are usually obtained if the reagent is dissolved or diluted shortly before being used for test purposes.
Since the shelf life of a reagent in dry form is usually longer than the shelf life of the reagent in a liquid condition it is common practice to maintain a reagent in dry condition in a reagent mixing package. In some instances, the mixing package is arranged to hold in segregated condition a dry reagent component and a liquid reconstituting component. When use of the reagent is desired, the components are intermixed within the package.
One known reagent package such as shown in U.S. Pat. No. 4,515,753 includes a reagent in lyophilized powder form in a first breakable capsule and a reconstituting liquid for the reagent in a second breakable capsule. The capsules are broken by compressing the package to release the contents of each capsule for mixing within the package. An outlet port in the package permits outside access to the mixed ingredients. Although this reagent package provides a freshly mixed reagent for immediate use in a sample analysis system, it is difficult to seal the package once the ingredients have been mixed. This package also does not permit long term preservation of liquid that is openly contained in the package and therefore the reconstituting liquid must be maintained in a capsule.
It is thus desirable to provide a reagent package that can be sealed when it is in storage awaiting use and also provide for sealing of the package after the package contents are mixed for use.
Generally, the liquid mixture contained in the reagent package is one of the most expensive consumable constituents of a sample analysis system. For example the contents of an individual reagent package can cost approximately $600 to $1,000 for approximately 20 to 25 milliliters of mixed reagent.
It is thus beneficial to be able to conveniently withdraw substantially all of the liquid reagent that is mixed in a reagent package. It is also desirable that such withdrawal of reagent be free of any fragmentary glass particles that result from breakage of a glass ampoule in the package after the arnpoule is broken to release a constituent of the reagent mixture.
It is also desirable to provide a reagent package for one or more reagent components wherein the package has a valve controlled opening that can also be sealed independently of the valve, and which package permits use of substantially all of the mixed ingredients in the reagent package without contamination from glass particles after an ampoule is broken in the reagent package.